Herbal preparations for uterine fibroids

 

Abstract

Background

Uterine fibroids are the most common non-malignant growths in women of childbearing age. They are associated with heavy menstrual bleeding and subfertility. Herbal preparations are commonly used as alternatives to surgical procedures.

Objectives

To assess the benefits and risks of herbal preparations for uterine fibroids.

Search methods

Authors searched following electronic databases: the Trials Registers of the Cochrane Menstrual Disorders and Subfertility Group and the Cochrane Complementary Medicine Field, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 3), MEDLINE, EMBASE, the Chinese Biomedical Database, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), AMED, and LILACS. The searches ended on 31st December 2008.

Selection criteria

Randomised controlled trials comparing herbal preparations with no intervention, placebo, medical treatment or surgical procedures in women with uterine fibroids. We also included trials of herbal preparations with or without conventional therapy.

Data collection and analysis

Two review authors collected data independently. We assessed trial risk of bias according to our methodological criteria . We presented dichotomous data as risk ratios (RR) and continuous outcomes as mean difference (MD), both with 95% confidence intervals (CI).

Main results

We included two randomised trials (involved 150 women) with clear description of randomisation methods. The methodological risk of bias of the trials varied. There were variations in the tested herbal preparations, and the treatment duration was six months. The outcomes available were not the primary outcomes selected for this review, such as symptom relief or the need for surgical treatment; trials mainly reported outcomes in terms of shrinkage of the fibroids.

Compared with mifepristone, Huoxue Sanjie decoction showed no significant difference in the disappearance of uterine fibroids, number of patients with shrinking of uterine fibroids or average volume of uterine fibroids, but less effective than mifepristone on reducing average size of uterus (mean difference 23.23 cm³,95% confidence interval 17.85 to 28.61). There was no significant difference between Nona Roguy herbal product and GnRH agonist in average volume of uterine fibroids or size of uterus. No serious adverse effects from herbal preparations was reported.

Authors' conclusions

Current evidence does not support or refute the use of herbal preparations for treatment of uterine fibroids due to insufficient studies of large sample and high quality. Further high quality trials evaluating clinically relevant outcomes are warranted.

 

Plain language summary

Herbal preparations for the treatment of women with uterine fibroids

Uterine fibroids are benign (non cancerous) growths in the uterus. They are the most common type of growth found in a women's pelvis, being present in about one in four or five women older than 35 years. Although many women with fibroids are not aware of them,the growths may cause symptoms or problems due to their size, number, or location. Common symptoms can include longer or more frequent menstrual periods, heavy bleeding, menstrual pain, pressure in the lower abdomen, infertility, or miscarriages. Women with these symptoms will require treatment. Fibroids can be treated with surgery, such as myomectomy (removal of the fibroids while leaving the uterus in place) or hysterectomy (removal of the uterus). Another approach is uterine artery embolization, by which the blood vessels to the uterus are blocked. Drugs, such as gonadotropin-releasing hormone (GnRH) agonists, may be used to shrink fibroids and to control bleeding.

Herbal preparations are commonly used alternatives for drug treatment, surgery, or both. This systematic review included two randomised clinical trials involving 150 women with uterine fibroids. Compared with medication, two herbal preparations may have similar beneficial effect on the shrinkage of uterine fibroids or uterus. However, these clinical trials are small in terms of the number of participants and the trial quality varied. The effect of herbal preparations for uterine fibroids therefore needs to be studied in further large, good quality trials.

 

摘要

背景

以草本製劑治療子宮肌瘤

子宮肌瘤係生育年齡婦女最常見之非惡性生長腫瘤。其與嚴重之經期出血及生育力低下有關。草本製劑常被用於作為手術治療之替代選擇。

目標

評估以草本製劑治療子宮肌瘤的效益及風險。

搜尋策略

作者搜尋以下電子資料庫: Trials Registers of Cochrane Menstrual Disorders and Subfertility Group and Cochrane Complementary Medicine Field、Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2008, Issue 3) 、MEDLINE、EMBASE、Chinese Biomedical Database, the Traditional Chinese Medical Literature Analysis以及Retrieval System (TCMLARS) 、 AMED,以及LILACS。搜尋結束時間為2008年12月31日。

選擇標準

針對患有子宮肌瘤之婦女，比較草本製劑與無干預措施、安慰劑、藥物治療或手術治療的隨機對照試驗。我們亦收錄了在有或無習知治療之情形下使用草本製劑的試驗。

資料收集與分析

由2位回顧作者獨立收集數據。茲根據我們的方法學標準評估試驗之偏差風險。我們以風險比 (risk ratio；RR) 表示二元數據，並以平均差 (mean difference；MD) 表示連續結果，兩著皆結合其95% 信賴區間 (confidence interval；CI) 。

主要結論

共收錄2項清楚敘述其隨機分派方法之隨機試驗 (包括150名婦女) 。該等試驗之方法學偏差風險各異。所試驗之草本製劑各有不同，而治療之持續期為6個月。可得之結果並非本回顧所選擇之首要結果，諸如症狀之減輕或是手術治療之需求；試驗主要僅就肌瘤之縮小而報告結果。相較於mifepristone，就子宮肌瘤之消失、子宮肌瘤縮小病患之數目、或是子宮肌瘤之平均體積而言，Huoxue Sanjie湯顯示並顯著之差異，但其就減少子宮平均大小而言不如mifepristone般有效 (平均差 23.23 cm3, 95% 信賴區間17.85 to 28.61) 。就子宮肌瘤之平均體積或子宮大小而言，Nona Roguy草本產品與GnRH激動劑並無顯著之差異。並無有關草本製劑嚴重不良作用之報告。

作者結論

由於沒有足夠之大樣本及高品質研究，目前的證據並無法支持或反駁使用草本製劑進行子宮肌瘤之治療。茲需要評估臨床相關結果之進一步高品質試驗。

翻譯人

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

子宮肌瘤是子宮中之良性 (非癌性) 生長。其為女性骨盆腔中最常見之生長類型，存在於約四或五分之一的35歲以上婦女。儘管諸多具有肌瘤之婦女並不知道其存在，該等生長情形可能會因其大小、數目、或位置而造成症狀或問題。常見之症狀可包括較常或較高頻率之經期、大量出血、經痛、下腹部之壓力、不孕、或流產。具有此等症狀之婦女需要進行治療。肌瘤可以手術治療，諸如肌瘤切除術 (除去肌瘤但保留子宮) 或子宮切除術 (除去子宮) 。另一種方法為子宮動脈栓塞術，其係阻斷子宮之血管。藥物，諸如促性腺激素釋放激素 (gonadotrophin releasing hormone；GnRH) 激動劑，可用於縮減肌瘤並控制出血。草本製劑常被用於作為藥物、手術、或兩者之替代選擇。本系統性回顧共收錄包括150名患有子宮肌瘤之婦女的2項隨機臨床試驗。相較於藥物，其中2種草本製劑對於子宮肌瘤或子宮之縮小可能具有類似之效益作用。然而，此等臨床試驗之參與者數目較小且試驗品質各異。應以進一步之大型、高品質試驗研究草本製劑對於子宮肌瘤之效應。